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用于美容应用的26毫克/毫升高分子量透明质酸稳定组合物的疗效和安全性。

Efficacy and Safety of a Stabilized Composition of 26 mg/mL of High Molecular Weight Hyaluronic Acid for Aesthetic Applications.

作者信息

Hadjab Basste, Gavard Molliard Samuel, Bon Bétemps Jérémie, Cerrano Marco, de Boccard Francesco, Finke Alexandre

机构信息

Department of Research and Development, Kylane Laboratoires SA, 1228 Plan-les-Ouates, Switzerland.

Aesthetic Surgery Department, Clinique Entourage, 1003 Lausanne, Switzerland.

出版信息

J Clin Med. 2025 Aug 26;14(17):6015. doi: 10.3390/jcm14176015.

Abstract

The growing demand for minimally invasive aesthetic procedures highlights the need for innovative injectable solutions that target skin aging beyond volumization. Hyaluronic acid (HA)-based fillers remain a cornerstone of aesthetic treatments, but traditional formulations often offer limited benefits in improving skin quality parameters such as elasticity. This study evaluated the efficacy and safety of an injectable formulation composed of 2.6% high molecular weight hyaluronic acid (H-HA) and 3.2% sorbitol, designed to improve skin biomechanical properties through subcutaneous administration. In this single-center, open-label, single-arm clinical trial, 86 participants aged 35 to 70 years received a single injection in the facial region. Clinical outcomes were assessed at baseline (day 0), one month (M1), and four months (M4) post-injection using the Global Aesthetic Improvement Scale (GAIS), instrumental Cutometer measurements of skin elasticity and recovery, and patient satisfaction questionnaires. Significant improvements in skin elasticity and recovery were observed at M4 following a single administration. The product was well tolerated, with only mild and transient injection site reactions observed. These exploratory findings support the clinical benefit of combining high-concentration H-HA with sorbitol to enhance skin quality in a safe and minimally invasive manner. These preliminary results position this formulation as a promising option for facial rejuvenation, targeting biomechanical improvement through a single-session injectable protocol.

摘要

对微创美容手术日益增长的需求凸显了对创新注射解决方案的需求,这些解决方案不仅能增加容积,还能针对皮肤老化问题。基于透明质酸(HA)的填充剂仍然是美容治疗的基石,但传统配方在改善皮肤质量参数(如弹性)方面往往益处有限。本研究评估了一种由2.6%高分子量透明质酸(H-HA)和3.2%山梨醇组成的注射制剂的疗效和安全性,该制剂旨在通过皮下给药改善皮肤生物力学性能。在这项单中心、开放标签、单臂临床试验中,86名年龄在35至70岁之间的参与者在面部区域接受了单次注射。在注射后基线(第0天)、1个月(M1)和4个月(M4)使用全球美容改善量表(GAIS)、皮肤弹性和恢复的仪器测量以及患者满意度问卷评估临床结果。单次给药后,在M4时观察到皮肤弹性和恢复有显著改善。该产品耐受性良好,仅观察到轻微和短暂的注射部位反应。这些探索性结果支持将高浓度H-HA与山梨醇联合使用以安全且微创的方式改善皮肤质量的临床益处。这些初步结果将该制剂定位为面部年轻化的一个有前景的选择,通过单次注射方案针对生物力学改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/146f/12428844/ceb0fb045135/jcm-14-06015-g001.jpg

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